A Phase 1 interventional study of Stem/progenitor cells transplantation in Retinal Degeneration, Retinitis Pigmentosa and Age Related Macular Degeneration, sponsored by Pomeranian Medical University Szczecin. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-12-17.
Sponsored by Pomeranian Medical University Szczecin · Phase 1, Interventional, and Other
The purpose of this study is to test the safety and effectiveness of an autologous bone marrow-derived stem/progenitor cells administered intravitreously in the subjects with degenerative diseases of the retina.
Degenerative diseases of the retina are challenging for ophthalmologists. This is a common term that covers heterogenous group of diseases, f.e. retinitis pigmentosa, Stargardt disease, Best's disease or age related macular degeneration. Undetermined etiology, wide range of factors that may trigger the onset of the disease and modulate it's course impede the implementation of an effective treatment. Currently, a stem cells therapy seems to be promising option in patients with degenerative diseases of the retina. The purpose of this prospective, nonrandomized, open label, pilot study is to conduct the investigation of the safety and efficacy of intravitreal injection of autologous bone marrow-isolated stem/progenitor cells with different selected phenotypes into the subjects with degenerative diseases of the retina. Especially, this clinical trial is designated to test the therapeutic (pro-regenerative and neuro-protective) functions of different stem/progenitor cell populations able to secrete bioactive neurotrophic factors. All patients enrolled will have a documented history of degenerative disease of the retina prior to study enrollment. Next, autologous bone marrow-isolated stem/progenitor cells intravitreous injection will be performed. Finally, treatment safety, adverse events and exploratory parameters, including best corrected visual acuity, visual field and electroretinography parameters, to establish disease progression rate will be recorded throughout the duration of the post-treatment follow up period.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's planned enrollment of 30 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Pomeranian Medical University Szczecin is the lead sponsor of 68 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention: A single intravitreal injection of autologous bone marrow-derived stem/progenitor cells will be performed.
Biological: Stem/progenitor cells transplantation
Symptomatic treatment of degenerative disease of retina without biologic cell-based treatment
Biological: Stem/progenitor cells transplantation
Human autologous bone marrow-derived stem/progenitor cell transplantation administered as an intravitreal injection in patients with degenerative disease of retina.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Confirm the safety of autologous bone marrow stem/progenitor cell intravitreal injection in enrolled patients by repeated follow-up over one year with clinical evaluations.
Time frame: 12 months
Efficacy of autologous bone marrow stem/progenitor intravitreal injection in enrolled patients.
Best corrected visual acuity, ETDRS chart \[number of letters\]
Time frame: 12 months
Intraocular pressure
Pascal tonometer \[mmHg\]
Time frame: 12 months
Optic disk retinal nerve fiber layer
optical coherence tomography \[um\]
Time frame: 12 months
Central macular thickness
optical coherence tomography \[um\]
Time frame: 12 months
Ganglion cell complex thickness
optical coherence tomography \[um\]
Time frame: 12 months
Choroidal thickness
Enhanced depth imaging optical coherence tomography \[um\]
Time frame: 12 months
Choroidal volume
Enhanced depth imaging optical coherence tomography \[mm3\]
Time frame: 12 months
Computed perimetry (30-2 and 10-2 module)
mean deviation, pattern standard deviation \[B\]
Time frame: 12 months
Goldmann perimetry with color filters
\[degrees\]
Time frame: 12 months
Contrast sensitivity
Pelli-Robson chart \[number of letters\]
Time frame: 12 months
Function of the photoreceptors (rods and cones), inner retinal cells (bipolar and amacrine cells), and ganglion cells.
Electroretinography (ERG) examination: * amplitude of a and b waves \[V\], * culmination time of a and b waves \[s\], * culmination time of q1-q3 waves \[s\].
Time frame: 12 months
Function of the photoreceptors
Multifocal electroretinography (mfERG) examination: * retinal response density \[V/degree 2\], * culmination time of P1 wave in 6 rings \[s\].
Time frame: 12 months
Function of ganglion cells
Pattern electroretinography (PERG) examination: * amplitude of P50 and N95 waves \[V\], * culmination time of P50 wave \[s\].
Time frame: 12 months
Plan to share: No
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This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Pomeranian Medical University Szczecin